Trial Information

A Two-Stage Multicenter Phase II Trial of Concurrent Panitumumab Immunotherapy, Cisplatin Chemotherapy and Pelvic Radiotherapy for Primary Cancer of the Uterine Cervix Stage IB-IIIB

OBJECTIVES:

Primary

- To assess the activity of concurrent panitumumab and cisplatin chemoradiotherapy in
patients with stage IB-IIIB, KRAS-wild type (KRAS^wt) cervical cancer, in terms of
progression-free survival at 4 months by MRI according to RECIST criteria.

- To assess the rate of skin toxicity (e.g., photosensitivity, acneiform rash, and
dermatitis) CTCAE grade 4 and/or gastrointestinal toxicity (comprising all grades of
gastrointestinal perforation; leakage of stomach, small intestine, colon, rectum, or
elsewhere in the peritoneal cavity occurring after the first application of study
treatment and not immediately related to a surgical procedure) at 4 months, of this
regimen in these patients.

Secondary

- To assess the activity of this regimen in KRAS^wt-positive and -negative patients, in
terms of overall response rate at 4 months.

- To assess the activity of this regimen in KRAS^wt-positive and -negative patients, in
terms of progression-free survival at 12 months and 24 months.

- To assess the activity of this regimen in KRAS^wt-positive and -negative patients, in
terms of overall survival at 12 months and 24 months.

- To assess the rate of severe adverse events of this regimen in patients with KRAS^wt
and KRAS-mutant gene status at 4 months.

- To assess the rate of post-treatment severe adverse events at 12 months and 24 months.

- To assess the rate of severe adverse events of panitumumab monotherapy at day 14.

OUTLINE: This is a multicenter study.

Patients receive panitumumab IV on days 1, 14, 29, and 43 and cisplatin IV on days 14, 22,
29, 36, 43, and 50 in the absence of disease progression or unacceptable toxicity. Patients
undergo concurrent external-beam and intracavitary radiotherapy (teletherapy of pelvis or
high-dose rate brachytherapy) according to treating center specific standards.

Blood and tissue specimens are collected periodically for laboratory analysis.

After completion of study treatment, patients are followed periodically for up to 2 years.